This invention relates generally to fluid specimen containers, testing devices for conducting chromatographic reaction tests using assay testing strips for fluid specimens and more particularly to sealed receptacles for holding fluid specimens and having testing capability.
Fluid specimen jars or cups are commonly used to collect and test fluid specimens for the presence or absence of specific xe2x80x9cindicatorsxe2x80x9d which show the presence of specific chemicals, hormones, antibodies or antigens and are most commonly used for drug screening.
Collecting and testing fluid specimens carries a health risk for the person conducting the test and a contamination risk to the specimen or testing media. Testing devices as disclosed in Cipkowski U.S. Pat. No. 5,976,895 have required that a specimen be placed in a specimen cup and that a technician manually insert and submerge a portion of a testing strip into the specimen. With a potential for contact with the sample by the operator or technician and its associated health and contamination risks, a sealed receptacle for preventing contact is desirable. Various devices show further reduction in the risk of contact as in U.S. Pat. No. 4,976,923 to Lipsky et al., and U.S. Pat. No. 5,429,804 to Sayles, which utilize a one-step testing device, with chromatographic testing strips mounted in their lids. The initiation of the testing procedure may be further controlled by a frangible partition allowing passage of the fluid through to the test strips as described in Davis U.S. Pat. No. 5,119,830. All of the above-mentioned prior devices allow the specimen volume, as a whole, to be in contact with the test strip. In other words, the portion of the specimen in contact with the stips is also capable of contacting and intermingling with the remainder of the specimen.
Oftentimes, the results of a particular test will indicate that further more rigorous testing should occur. For example, if an initial test comes back positive for drug use, the conductors of the test may seek to conduct a more rigorous and accurate test to confirm the presence of the offending component. However, this secondary test cannot be performed on the fluid specimen as originally supplied because the first test exposed the specimen to the chemicals carried on the test strip. Such exposure allows for intermingling of chemicals carried on the test strip with the volume of specimen thereby contaminating it. In the past, this problem has been addressed by taking multiple specimens or being forced to take specimens removed in time from when the original specimen was taken. One can easily appreciate that the taking of a subsequent specimen after a prolonged period allows for changes in the physiology of the test subject. For example, a person suspected of taking drugs can cease drug use whereupon tests taken days later may not turn up positive.
Various specimen-collecting and testing jars have been proposed that provide for two amounts of the specimen to be separated from one another. In this way, the first amount can be subjected to the test strips without contaminating the second amount of fluid. Such devices suffer from being bulky, difficult to operate, expensive to manufacture and provide less that adequate amounts of fluid for conducting the test. For example, the device of Guirguis U.S. Pat. No. 6,277,646 provides for only a limited amount or aliquot of fluid for testing, thereby making it potentially difficult to adequately contact the multiple strips. Also, the introduction of the aliquot can increase pressure in the test chamber to a degree which can effect test accuracy.
Many tests require viewing of results in a specific time frame after the test is initiated. Therefore, it is preferable that the donor not initiate the test.
Increasingly, tests are being performed and evaluated by relatively unskilled technicians. Therefore, the device needs to be relatively simple to operate to insure adequate exposure of the test strip and to provide accurate results. Devices that require precise actions by the tester such as the proper orientation of the strips during testings are a source for additional error.
U.S. Pat. No. 5,403,551 Galloway requires inversion to an unspecified angle making engaging adequate submersion of the test strips difficult and uncertain. Further, testing chambers that allow the flow of fluid onto the test strip upon inversion, also allow the fluid to escape upon righting. Such action can encourage the trapping of air bubbles on the strip, thereby inhibiting the capillary action required by most test strips. Testing accuracy is often enhanced by proper orientation of the strips. Most prior devices do not provide for such orientation.
Because of the need to avoid contamination or even the appearance of possible contamination, it is desired that the specimen test cups be disposable. Therefore, to maintain low cost, it is important that efficient manufacturing methods, low cost materials and low cost designs are provided.
Presently, test results are viewed by examining the test strip directly and manually interpreting and recording the results. Therefore, these results can be subjective and without objective proof after the test strip has been used and/or discarded.
There is, therefore, a need to insure proper testing by allowing the test strips to be in continuous and controlled contact with the fluid sample, to properly orient test strips, to enhance the simplicity of the testing procedures, to prevent the formation of air bubbles adjacent to the strips, to maintain proper pressure in the test chamber, to be inexpensive to manufacture, to be flexible in accommodating different types of testing procedures, to provide for a portion of the specimen volume to be uncontaminated by the testing process, and to provide more objective recordation of test results.
The principal and secondary objects of this invention are to provide a flexible, cost effective fluid specimen testing device which can easily be filled, closed and the test conducted, and one which provides for a portion of the volume of fluid to be separated and maintained in an uncontaminated condition during and after testing is complete and one in which the results are recorded more objectively.
These and other valuable objects are achieved by fluid specimen testing device which has two chambers, each of which is sealable by a lid. A sealable passageway converts the two chambers and is operable by the tester which allows a portion of the fluid specimen to pass therethrough and, after sealing, to be separated from, and uncontaminated by, any testing done to the other portion of the fluid. Testing strips are mounted behind a top viewing window in one of the removable lids. The device is adapted to provide stability in an upright, inverted, or tilted on its side orientation. A roll-inhibiting feature acts as an indicator of proper roll orientation in the tilted position. The test strips are also oriented in the lid so that they are substantially vertical when the device is in the tilted position, thereby enhancing a condition for proper capillarity. The strips are mounted close to the lid""s upper transparent surface which allows it to be copied on a flat glass copier providing for more objective recordation of test results. The opening and closing of the passageway is effected by a simple twisting motion between the threaded top portion and bottom portions of the cup. The top portion has a raised and shaped floor which provides a capture sump for keeping a portion of the specimen volume in the upper chamber while the passageway is open.